Shared Decision Making to Improve Care and Outcomes for Children With Autism
NCT ID: NCT01921244
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2013-08-31
2015-07-31
Brief Summary
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The primary goal of this study is to modify a previously published decision aid about use of medication to manage challenging behaviors in children with autism to make it easy to implement in practice and then evaluate this version in terms of proximal decisional outcomes and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral Pediatric clinic will be enrolled and randomly allocated to intervention or control (treatment as usual) groups. Initially, providers randomized to the intervention group will test and refine the modified intervention. Once the intervention is finalized, eligible patients of participating providers will be enrolled in the randomized controlled trial to test the efficacy of the intervention. Following the trial, control group providers will be crossed over and receive the intervention. Both proximal decisional outcomes (e.g. parent decisional conflict, provider amount of SDM, parent knowledge of treatment options) and outcomes 3 months later (e.g. parenting stress, decisional conflict, and change in child behavioral symptoms) will be assessed.
Approximately 10 providers and 240 of their patients with autism will be included in the study. Chart reviews, parental surveys, and recordings of provider-parent-patient interactions during the index visit will be collected at baseline (prior to physician allocation), during the intervention trial, and after the control group has crossed over. Between- and within-group analyses will examine factors associated with parental decisional conflict and whether the intervention produces significant improvements in outcomes over and above typical autism care. Analyses will include multiple linear regression modeling and general linear models / repeated measure models, accounting for data clustered by provider.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
Approximately 120 families will be asked to participate as "usual care" subjects and will complete surveys before and immediately after their visit, and approximately 3 months after the visit. These families will not receive the decision aid nor will their provider have been trained how to use the decision aid. All participating providers will have up to 10 "usual care" patients enrolled at baseline prior to allocation. During the trial, the control group \["usual care" providers\] will have up to 10 additional patients enrolled for ongoing "usual care" data collection. After the trial is complete, the control group providers will cross over to the intervention arm.
No interventions assigned to this group
Intervention
Approximately 80 families/patients with regularly scheduled clinic follow-up visits in the Division of Developmental and Behavioral Pediatrics (DDBP) at Cincinnati Childrens with providers trained on shared decision making will receive the decision aid prior to their index visit and complete surveys before and immediately after their visit, and approximately 3 months later.
Decision Aid
Parents will receive an intervention modified from the previously published tool called "Autism: Should My Child Take Medicine for Challenging Behavior?" This packet provides parents with educational information, elicits parent ratings of particular behavioral domains, describes behaviors that are and are not amenable to medication treatment, and elicits parent preferences regarding treatment. Providers will be trained on use of the intervention in practice to promote shared decision making during clinical encounters.
Interventions
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Decision Aid
Parents will receive an intervention modified from the previously published tool called "Autism: Should My Child Take Medicine for Challenging Behavior?" This packet provides parents with educational information, elicits parent ratings of particular behavioral domains, describes behaviors that are and are not amenable to medication treatment, and elicits parent preferences regarding treatment. Providers will be trained on use of the intervention in practice to promote shared decision making during clinical encounters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Providers must be a licensed professional, either a physician (MD) or a nurse practitioner (APN) in the Division of Developmental and Behavioral Pediatrics at Cincinnati Children's Hospital.
* Provider must regularly treat patients within the age range and for the diagnoses of interest in this study (Autism Spectrum Disorders).
Parents
* Participants must be a parent or legal guardian who self-identifies as the primary caregiver of a child or adolescent with Autism Spectrum Disorder cared for by an enrolled provider in the Division of Developmental and Behavioral Pediatrics at Cincinnati Children's Hospital.
* Participants must be able to speak and read English in order to complete the surveys
Children
* Child or adolescent must have a clinical diagnosis of Autism Spectrum Disorder including one of the following diagnoses: a) Pervasive Developmental Disorder (PDD), b) Asperger's Syndrome, c) Autism Spectrum Disorder, d) Autism, e) Infantile Autism
* Child or adolescent must be between the ages of 4 years 0 months and 15 years 11 months
* Child or adolescent must be scheduled for a follow up visit with a Developmental-Behavioral Pediatric provider enrolled in the study.
Exclusion Criteria
4 Years
15 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Julia Anixt, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Frazier TW, Shattuck PT, Narendorf SC, Cooper BP, Wagner M, Spitznagel EL. Prevalence and correlates of psychotropic medication use in adolescents with an autism spectrum disorder with and without caregiver-reported attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Dec;21(6):571-9. doi: 10.1089/cap.2011.0057. Epub 2011 Dec 13.
Nickels K, Katusic SK, Colligan RC, Weaver AL, Voigt RG, Barbaresi WJ. Stimulant medication treatment of target behaviors in children with autism: a population-based study. J Dev Behav Pediatr. 2008 Apr;29(2):75-81. doi: 10.1097/dbp.0b013e31815f24f7.
Blum NJ, Feldman HM, Barbaresi WJ, Schonfeld DJ, Hansen RL, Forrest CB. Research priorities for developmental-behavioral pediatrics: a DBPNet consensus study. J Dev Behav Pediatr. 2012 Jul;33(6):509-16. doi: 10.1097/DBP.0b013e31825a7101.
O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl Variation:VAR63-72. doi: 10.1377/hlthaff.var.63.
Fiks AG, Mayne S, Localio AR, Feudtner C, Alessandrini EA, Guevara JP. Shared decision making and behavioral impairment: a national study among children with special health care needs. BMC Pediatr. 2012 Sep 21;12:153. doi: 10.1186/1471-2431-12-153.
Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. doi: 10.1002/14651858.CD001431.pub3.
Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
Fowler FJ Jr, Levin CA, Sepucha KR. Informing and involving patients to improve the quality of medical decisions. Health Aff (Millwood). 2011 Apr;30(4):699-706. doi: 10.1377/hlthaff.2011.0003.
Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
Brinkman WB, Hartl J, Rawe LM, Sucharew H, Britto MT, Epstein JN. Physicians' shared decision-making behaviors in attention-deficit/hyperactivity disorder care. Arch Pediatr Adolesc Med. 2011 Nov;165(11):1013-9. doi: 10.1001/archpediatrics.2011.154.
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
Brinkley J, Nations L, Abramson RK, Hall A, Wright HH, Gabriels R, Gilbert JR, Pericak-Vance MA, Cuccaro ML. Factor analysis of the aberrant behavior checklist in individuals with autism spectrum disorders. J Autism Dev Disord. 2007 Nov;37(10):1949-59. doi: 10.1007/s10803-006-0327-3. Epub 2006 Dec 21.
Zaidman-Zait A, Mirenda P, Zumbo BD, Georgiades S, Szatmari P, Bryson S, Fombonne E, Roberts W, Smith I, Vaillancourt T, Volden J, Waddell C, Zwaigenbaum L, Duku E, Thompson A; Pathways in ASD Study Team. Factor analysis of the Parenting Stress Index-Short Form with parents of young children with autism spectrum disorders. Autism Res. 2011 Oct;4(5):336-46. doi: 10.1002/aur.213. Epub 2011 Aug 31.
Related Links
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Other Identifiers
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FP00005038
Identifier Type: -
Identifier Source: org_study_id
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